Biosafety Engineer

Biosafety Engineer

Materialise

Leuven, Belgium

Are you interested in additive manufacturing activities in a medical environment? Are you passionate about patient safety? Would you love to work at the crossroads between engineering and biology? Then, we are looking for you to complete our team as a Biosafety Engineer. 

What you will do

• Within our medical business unit, you'll join a team of specialists who ensure the biocompatibility of our medical devices to develop and validate their cleaning, packaging, and sterilization processes;
• Participate in medical device development by supporting biological safety evaluations in accordance with ISO 10993-1 and executing cleaning and sterilization process validations;
• Develop new or optimized packaging for sterile and non-sterile medical devices and test their performance;
• Set up and take part in monitoring programs to ensure the continued fulfillment of requirements;
• Contribute to regulatory submissions of new devices;
• Build a thorough understanding of the manufacturing process, especially the steps related to cleaning, packaging, and sterilization, to effectively plan new development and validation activities;
• Create and finalize validation protocols and reports, ensuring they are clear, concise, and compliant with work instructions and standards;
• Assess the impact of the process or product changes and propose adequate actions;
• Plan and follow up on test sample production with the manufacturing team and suppliers;
• Coordinate tests performed at external test labs;
• Interact closely with internal stakeholders (including the quality, development, process engineering, and manufacturing teams) and external partners (including test labs and suppliers) to ensure good communication and swift collaboration;
• Act as an ambassador and safeguard biological safety within Materialise Medical.

Your profile

• Master's degree (engineering, biochemistry, biology, or medical);
• Knowledge and understanding of regulatory requirements, standards, and guidance documents in the field of biocompatibility evaluation, cleaning validation, packaging development, or sterilization validation of medical devices;
• Able to work on multiple projects simultaneously, set priorities, and establish short and long-term planning horizons;
• Effective as a team member in accomplishing project deadlines and objectives, yet able to work and make decisions independently to reach goals;
• Clear and effective verbal communication and technical writing skills in English;
• Good analytical skills, meticulous approach with a high level of attention to detail;
• Passionate about patient safety and customer satisfaction;
• Previous experience in the medical device industry is a plus.